Hemab Therapeutics, a clinical-stage biotechnology company, announced on Fridayp its initial outcome from phase one of its ongoing assessment of HMB-001.
The product, a novel bispecific antibody, is in development as a prophylactic treatment for the bleeding disorder Glanzmann Thrombasthenia (Glanzmann). The data was showcased as one of 10 abstracts chosen for the SLAM oral presentation session at the 17th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD) held this week in Frankfurt, Germany.
The study is assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of the product. Under the UK-based Phase one single-ascending dose, seven subjects received subcutaneous HMB-001 at 0.2mg/kg, (n=1), 0.5mg/kg (n=3) or 1.25mg/kg (n=3). During 56-day observation period, the product was well tolerated, with the most common adverse events (AEs) mild or moderate in severity. The product did not indicate any AEs or serious adverse events. The study did not reveal any dose-limiting toxicities and no thromboembolic events reported.
Joe Vogel, senior director and Program Lead for HMB-001 at Hemab, said, 'The first clinical data for HMB-001 in Glanzmann suggest that the demonstrated mechanism is suitable as a new prophylactic treatment for people with neglected blood clotting disorders who face severe, potentially life-threatening bleeds every day. With Phase two already underway, we are committed to advancing clinical evaluation of HMB-001 toward bringing life-changing preventative treatments to improve patients' quality of life.'
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